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Two placebo-controlled crossover studies in healthy subjects to evaluate gastric acid neutralization by an alginate-antacid formulation (Gaviscon Double Action).
- Source :
- Drug Development & Industrial Pharmacy; Mar2019, Vol. 45 Issue 3, p430-438, 9p
- Publication Year :
- 2019
-
Abstract
- Objective: To investigate the intragastric acid neutralization activity of a combined alginate-antacid formulation. Significance: Published studies have investigated the reflux-suppressing alginate component of Gaviscon Double Action (Gaviscon DA; RB, UK) but intragastric acid neutralization activity of the antacid component has not been evaluated in vivo. Methods: Intragastric pH monitoring, using a custom-made 10-electrode catheter, was evaluated in a two-part exploratory study in healthy subjects; Part I (n = 6) tested suitability of the catheter using antacid tablets (Rennie; Bayer, Germany); Part II (n = 12) evaluated gastric acid neutralization activity of Gaviscon DA liquid (20 ml) versus placebo in fasted subjects using a randomized, open-label, crossover design. The primary endpoint was the percentage of time that intragastric pH ≥4 was measured during 30 min post-treatment. A confirmatory study of identical design was subsequently conducted (n = 20). Results: Monitoring pH using the multielectrode catheter was a viable approach, directly detecting changes in intragastric pH following a single dose of antacid tablets. In the exploratory study, the percentage of time that pH ≥4 during 30 minutes post-treatment was 46.8% with Gaviscon DA liquid versus 4.7% with placebo (p = 0.0004). These findings were supported by the confirmatory study, where pH ≥4 was recorded 50.8% of the time with Gaviscon DA versus 3.5% with placebo (p = 0.0051). In this study, Gaviscon DA was safe and well tolerated. Conclusions: These studies demonstrate the effective acid neutralizing capacity of Gaviscon DA versus placebo in healthy, fasted subjects. This adds to the evidence base for the combination of alginates and antacids. [ABSTRACT FROM AUTHOR]
- Subjects :
- GASTRIC acid
ALGINATES
CATHETERS
ANTACIDS
PLACEBOS
Subjects
Details
- Language :
- English
- ISSN :
- 03639045
- Volume :
- 45
- Issue :
- 3
- Database :
- Complementary Index
- Journal :
- Drug Development & Industrial Pharmacy
- Publication Type :
- Academic Journal
- Accession number :
- 134891543
- Full Text :
- https://doi.org/10.1080/03639045.2018.1546314